Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap, yoke) and cross bar connector assemblies.
This recall has been terminated (originally issued April 22, 2015).
- Company
- X Spine Systems Inc
- Recall Initiated
- March 11, 2015
- Posted
- April 22, 2015
- Terminated
- October 21, 2015
- Recall Number
- Z-1512-2015
- Quantity
- 14 units
- Firm Location
- Miamisburg, OH
- Official Source
- View on FDA website ↗
Reason for Recall
One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x 55mm instead of 5.5 x 55mm as described on the product label.
Distribution
US Distribution to states of: KS, NV & TX.
Lot / Code Info
Lot #: 4084-01; M/N X073-5555; UDI: *+M697X07355551/$408401U*
Root Cause
Nonconforming Material/Component
Action Taken
The firm, X-spine Systems, Inc., sent an "Urgent Medical Device Recall" letter dated March 19, 2015 to their customers. The letter describes the product, problem and actions to be taken. The customers were instructed to notify affected hospital and surgeon of the recall immediately; complete the attached Medical Device Recall Return Response Form and return it with any affected product in inventory to X-Spine Systems immediately via mail: 725 Alexandersville Road, Miamisburg OH 45342-RMA #5288; and No action should be taken with product that has been implanted. Please contact customer service at 800.903.0640 or email orders@x-spine.com with any questions.